国产盐酸环丙沙星片及胶囊溶出度比较

目的: 比较国内不同药厂盐酸环丙沙星片剂和胶囊的溶出情况。 方法: 采用中国药典2005年版所述方法,测定了不同厂家盐酸环丙沙星片和胶囊在0.1 mol·L^-1盐酸溶液中的溶出曲线并采用相似因子法分析结果。同时考察了制剂在pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水3种溶出介质中的体外溶出行为。 结果: 片剂呈现5种溶出过程,胶囊呈现4种溶出过程,制剂在不同溶出介质中溶出行为不同。 结论: 不同厂家生产的制剂质量存在差异,国产药品的质量有待提高。

Objective: To evaluate the quality of ciprofloxacin hydrochloride tablets and capsules by determining the dissolution of tablets and capsules from different manufactures. Methods: The dissolubility of different ciprofloxacin hydrochloride products was determined with the related standard procedure indexed in China Pharmacopoeia (2005 edition).The dissolubility was also inspected in the following 3 mediums:pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution and water. Results: The cumulative dissolutions of tablets and capsules were shown 5 and 4 kinds of dissolution process respectively.The dissolution courses were different in different mediums. Conclusion: There are differences among the quality of ciprofloxacin hydrochloride tablets and capsules from different manufactures.The quality of domestic-made preparations needs to be improved.